Breast CancerQUALIPAPNCT07728565
Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
An observational study of Breast Cancer and Acquired Absence of Breast, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or unsuitable for reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Acquired Absence of Breast, Autologous Breast Reconstruction
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2026to 31 Aug 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap after mastectomy for breast cancer at the European Georges Pompidou Hospital between 2014 and 2024 and who are eligible for long-term quality-of-life and aesthetic outcome assessment.
Who may be able to join
- Female patients aged 18 years or older.
- History of unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap.
- Breast reconstruction performed between 2014 and 2024 at the European Georges Pompidou Hospital.
- Able to understand study procedures and complete study questionnaires.
- Provided non-opposition/consent to participate according to French regulations.
Who cannot join
- Patients younger than 18 years.
- Breast reconstruction performed using techniques other than PAP flap.
- Breast reconstruction performed outside the study period (2014-2024).
- Patients under legal protection measures.
- Severe cognitive impairment or major psychiatric disorder preventing questionnaire completion.
- Hearing impairment preventing participation in the interview process.
Show all 9Show fewer
- Insufficient French language proficiency.
- Missing essential clinical data.
- Explicit refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, 75015
Laurent Lantieri, MD, +33 1 56 09 58 72, laurent.lantieri@aphp.fr
About this study
Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or unsuitable for reconstruction. Although the PAP flap is increasingly used, limited data are available regarding long-term patient-reported quality of life, aesthetic outcomes, and donor-site morbidity.
This monocentric observational study aims to evaluate long-term quality of life in women who underwent breast reconstruction with a PAP flap at the European Georges Pompidou Hospital between 2014 and 2024. Participants will complete validated patient-reported outcome questionnaires (BREAST-Q Reconstruction Module and PROMIS-29) and undergo a standardized clinical and photographic assessment. Aesthetic outcomes will be evaluated using objective photographic analysis and blinded expert review.
The study will provide comprehensive information on patient satisfaction, functional outcomes, aesthetic results, and donor-site sequelae following PAP flap breast reconstruction.
Read the detailed description
Background
Autologous breast reconstruction is associated with improved patient satisfaction and quality of life after mastectomy. While the deep inferior epigastric perforator (DIEP) flap is considered the standard autologous reconstruction technique, the profunda artery perforator (PAP) flap has emerged as an effective alternative for patients lacking adequate abdominal donor tissue. Despite increasing use of the PAP flap, long-term evidence regarding patient-reported outcomes and objective aesthetic results remains limited.
Objective
The primary objective is to assess long-term quality of life after breast reconstruction using a PAP flap.
Secondary objectives include evaluation of aesthetic outcomes, donor-site morbidity, and correlations between objective and subjective measures of reconstructive success.
Study Design
This is a single-center, observational, non-interventional study conducted at the Department of Plastic Surgery, European Georges Pompidou Hospital (Paris, France).
Women who underwent unilateral or bilateral breast reconstruction using a PAP flap between 2014 and 2024 will be contacted and invited to participate.
Outcome Assessment Primary Outcome
Quality of life will be assessed using validated patient-reported outcome measures:
BREAST-Q Reconstruction Module (French version) PROMIS-29 Profile (French version)
Assessments will be performed at least two years after reconstruction.
Secondary Outcomes
Aesthetic outcomes will be evaluated through a multimodal approach including:
Standardized clinical photographs Objective photographic analysis using BCCT.core software Volumetric and symmetry assessment when available Blinded evaluation by a panel of plastic surgeons and lay reviewers
Additional analyses will explore the relationship between objective aesthetic measurements and patient-reported satisfaction.
Study Population
Approximately 264 women who underwent PAP flap breast reconstruction between 2014 and 2024 at the European Georges Pompidou Hospital will be eligible.
Significance
The study will provide valuable long-term data regarding quality of life, patient satisfaction, aesthetic outcomes, and donor-site sequelae after PAP flap breast reconstruction. These findings may improve patient counseling and optimize reconstructive decision-making for women undergoing breast cancer treatment.
- Keywords
- PAP Flap, Profunda Artery Perforator Flap, Breast Reconstruction, Autologous Breast Reconstruction, Quality of Life, BREAST-Q, PROMIS-29, Aesthetic Outcome, Donor Site Morbidity, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PAP Flap Breast Reconstruction | Women aged 18 years or older who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap following mastectomy for breast cancer between 2014 and 2024 at the European Georges Pompidou Hospital (Paris, France). Participants will complete BREAST-Q and PROMIS-29 questionnaires and undergo standardized clinical and photographic assessment to evaluate long-term quality of life, aesthetic outcomes, and donor-site morbidity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREAST-Q Reconstruction Module Domain Scores
Long-term patient-reported quality of life and satisfaction will be assessed using the BREAST-Q Reconstruction Module (French version). Domain scores are transformed to a 0-100 scale, where 0 represents the poorest outcome and 100 the best outcome. Higher scores indicate greater satisfaction and better health-related quality of life.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores
Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1, French version). Scores are reported as standardized T-scores (population mean = 50, SD = 10; typical observed range approximately 20-80). Higher scores indicate better health for the Physical Function and Ability to Participate in Social Roles domains, whereas higher scores indicate worse symptoms for Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity domains.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Secondary outcomes (4)
Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification
Aesthetic outcome will be evaluated using standardized clinical photographs analyzed with Breast Cancer Conservation Treatment cosmetic results (BCCT.core) software. Cosmetic results are classified into four categories: Excellent, Good, Fair, and Poor, with Excellent representing the best aesthetic outcome and Poor the worst aesthetic outcome.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Blinded Expert Panel Aesthetic Score
Standardized photographs will be independently evaluated by blinded plastic surgeons and lay reviewers using a 10-point Visual Analogue Scale (VAS; range 0-10) and a 5-point Likert scale (range 1-5). Higher scores indicate a better aesthetic outcome.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Breast Symmetry Assessment
Breast symmetry will be evaluated using objective photographic analysis and volumetric assessment when available. Greater symmetry (corresponding to smaller differences between reconstructed and contralateral breasts) indicates a better aesthetic outcome.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Donor Site Morbidity
Assessment of donor-site sequelae and scar-related outcomes at the posterior thigh donor site.
Measured: At study assessment, at least 2 years after PAP flap breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 264 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Lantieri, MD, Study chair, Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728565
- Sponsor's protocol ID
- APHP251552
- Acronym
- QUALIPAP
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Data are owned by Assistance Publique-Hôpitaux de Paris (AP-HP) and contain potentially identifiable health information. Requests for access to study data may be considered by the sponsor in accordance with applicable regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
- ClinicalTrials.gov ID
- NCT07728565
- Acronym / sponsor ID
- QUALIPAP / APHP251552
- Keywords
- PAP Flap, Profunda Artery Perforator Flap, Breast Reconstruction, Autologous Breast Reconstruction, Quality of Life, BREAST-Q, PROMIS-29, Aesthetic Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or unsuitable for reconstruction. Although the PAP flap is increasingly used, limited data are available regarding long-term patient-reported quality of life, aesthetic outcomes, and donor-site morbidity.
This monocentric observational study aims to evaluate long-term quality of life in women who underwent breast reconstruction with a PAP flap at the European Georges Pompidou Hospital between 2014 and 2024. Participants will complete validated patient-reported outcome questionnaires (BREAST-Q Reconstruction Module and PROMIS-29) and undergo a standardized clinical and photographic assessment. Aesthetic outcomes will be evaluated using objective photographic analysis and blinded expert review.
The study will provide comprehensive information on patient satisfaction, functional outcomes, aesthetic results, and donor-site sequelae following PAP flap breast reconstruction.
Detailed description
Background
Autologous breast reconstruction is associated with improved patient satisfaction and quality of life after mastectomy. While the deep inferior epigastric perforator (DIEP) flap is considered the standard autologous reconstruction technique, the profunda artery perforator (PAP) flap has emerged as an effective alternative for patients lacking adequate abdominal donor tissue. Despite increasing use of the PAP flap, long-term evidence regarding patient-reported outcomes and objective aesthetic results remains limited.
Objective
The primary objective is to assess long-term quality of life after breast reconstruction using a PAP flap.
Secondary objectives include evaluation of aesthetic outcomes, donor-site morbidity, and correlations between objective and subjective measures of reconstructive success.
Study Design
This is a single-center, observational, non-interventional study conducted at the Department of Plastic Surgery, European Georges Pompidou Hospital (Paris, France).
Women who underwent unilateral or bilateral breast reconstruction using a PAP flap between 2014 and 2024 will be contacted and invited to participate.
Outcome Assessment Primary Outcome
Quality of life will be assessed using validated patient-reported outcome measures:
BREAST-Q Reconstruction Module (French version) PROMIS-29 Profile (French version)
Assessments will be performed at least two years after reconstruction.
Secondary Outcomes
Aesthetic outcomes will be evaluated through a multimodal approach including:
Standardized clinical photographs Objective photographic analysis using BCCT.core software Volumetric and symmetry assessment when available Blinded evaluation by a panel of plastic surgeons and lay reviewers
Additional analyses will explore the relationship between objective aesthetic measurements and patient-reported satisfaction.
Study Population
Approximately 264 women who underwent PAP flap breast reconstruction between 2014 and 2024 at the European Georges Pompidou Hospital will be eligible.
Significance
The study will provide valuable long-term data regarding quality of life, patient satisfaction, aesthetic outcomes, and donor-site sequelae after PAP flap breast reconstruction. These findings may improve patient counseling and optimize reconstructive decision-making for women undergoing breast cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAP Flap Breast Reconstruction | – | –Women aged 18 years or older who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap following mastectomy for breast cancer between 2014 and 2024 at the European Georges Pompidou Hospital (Paris, France). Participants will complete BREAST-Q and PROMIS-29 questionnaires and undergo standardized clinical and photographic assessment to evaluate long-term quality of life, aesthetic outcomes, and donor-site morbidity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap after mastectomy for breast cancer at the European Georges Pompidou Hospital between 2014 and 2024 and who are eligible for long-term quality-of-life and aesthetic outcome assessment.
Key inclusion criteria (5 listed)
- Female patients aged 18 years or older.
- History of unilateral or bilateral breast reconstruction using a profunda artery perforator (PAP) flap.
- Breast reconstruction performed between 2014 and 2024 at the European Georges Pompidou Hospital.
- Able to understand study procedures and complete study questionnaires.
- Provided non-opposition/consent to participate according to French regulations.
Key exclusion criteria (9 listed)
- Patients younger than 18 years.
- Breast reconstruction performed using techniques other than PAP flap.
- Breast reconstruction performed outside the study period (2014-2024).
- Patients under legal protection measures.
- Severe cognitive impairment or major psychiatric disorder preventing questionnaire completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BREAST-Q Reconstruction Module Domain Scores
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Long-term patient-reported quality of life and satisfaction will be assessed using the BREAST-Q Reconstruction Module (French version). Domain scores are transformed to a 0-100 scale, where 0 represents the poorest outcome and 100 the best outcome. Higher scores indicate greater satisfaction and better health-related quality of life.
Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1) Domain Scores
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29 v2.1, French version). Scores are reported as standardized T-scores (population mean = 50, SD = 10; typical observed range approximately 20-80). Higher scores indicate better health for the Physical Function and Ability to Participate in Social Roles domains, whereas higher scores indicate worse symptoms for Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity domains.
4 secondary outcomes
Breast Cancer Conservation Treatment cosmetic results (BCCT.core) Aesthetic Classification
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Blinded Expert Panel Aesthetic Score
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Breast Symmetry Assessment
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Donor Site Morbidity
Time frame: At study assessment, at least 2 years after PAP flap breast reconstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Data are owned by Assistance Publique-Hôpitaux de Paris (AP-HP) and contain potentially identifiable health information. Requests for access to study data may be considered by the sponsor in accordance with applicable regulations and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Lantieri, MD study chair
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Acquired Absence of Breast, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Lhuaire, MD, PhD (+33 1 56 09 57 95, martin.lhuaire@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BREAST-Q Reconstruction Module Domain Scores (time frame: At study assessment, at least 2 years after PAP flap breast reconstruction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.